Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX | A217650 | TEVA PHARM
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AbbVie Inc. v. Teva Pharmaceuticals, Inc. et al 4 patentsANDA 217650elagolix sodium (eq. 300 mg base), estradiol (1 mg), and norethindrone acetate (0.5 mg) | D. Del. | 2023-11-07 | Terminated 2024-01-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.